Workshop 4: Adverse Drug Reactions
Workshop 4.1: Adverse Drug Reactions
|Case Scenario 1 |
|Question |I have just been prescribed Roaccutane( and have been told that I shouldn’t wax my legs. Will this be forever or |
| |is it only for the duration of time that I am on it? |
|What further background |PERSON |MEDICINES |
|information do you need to | | |
|clarify the question and | | |
|minimise the risks when | | |
|advising the caller? | | |
| |Who is asking? |Medicines (name,dose,freq)? |
| |19 year old female – about herself |Roaccutane( 30mg once a day. |
| | |Microgynon 30( . |
| |New or worsening symptoms? | |
| |No symptoms. |Why asking about medicines? |
| | |Would like further explanation of what the specialist |
| |Any allergies/medical conditions? |said. |
| |No allergies. Acne since mid teens. | |
|Gather the further background information BEFORE searching for information. |
|What information sources |eBNF: |
|would you use? |Roaccutane( contains isotretinoin. |
| |Counselling Warn patient to avoid wax epilation (risk of epidermal stripping), dermabrasion, and laser skin |
| |treatments (risk of scarring) during treatment and for at least 6 months after stopping; patient should avoid |
| |exposure to UV light (including sunlight) and use sunscreen and emollient (including lip balm) preparations from |
| |the start of treatment. |
| |Side-effects dryness of skin (with dermatitis, scaling, thinning, erythema, pruritus), epidermal fragility |
| |(trauma may cause blistering), dryness of lips (sometimes cheilitis), dryness of eyes (with blepharitis and |
| |conjunctivitis), dryness of pharyngeal mucosa (with hoarseness), dryness of nasal mucosa (with epistaxis) |
| |Cautions exclude pregnancy before starting (perform pregnancy test 2–3 days before expected menstruation, start |
| |treatment on day 2 or 3 of menstrual cycle)—women must practice effective contraception at least 1 month before, |
| |during, and for at least 1 month after treatment |
| | |
| |eMC – PIL/Roaccutane(: |
| |Possible side effects |
| |Roaccutane can have side effects, though not everybody gets them. The effects often wear off, or stop when |
| |treatment is stopped. Your doctor can help you deal with them. |
| |Skin and hair problems |
| |Very common effects (may affect more than 1 in every 10 people) |
| | |
| |Dryness of the skin, especially of the lips and face; inflamed skin, chapped and inflamed lips, rash, mild itching|
| |and slight peeling. Use a moisturising cream from the start of treatment. |
| |Skin becomes more fragile and redder than usual, especially the face. |
| | |
| |Women who could get pregnant are only prescribed Roaccutane under strict rules, because of the risk of birth |
| |defects (damage to the unborn baby). |
| |These are the rules: |
| |You must only take Roaccutane if you have severe acne that has not got better after any other anti-acne |
| |treatments, including antibiotics and skin treatments. |
| |Your doctor must have explained the risk of birth defects: you understand why you must not get pregnant and what |
| |you need to do to prevent it. |
| |You must have discussed contraception (birth control) with your doctor. They will give you information on |
| |preventing pregnancy. He or she may refer you to a specialist for contraceptive advice. |
| |You must agree to use one or preferably two effective methods of contraception, including condoms or a cap plus |
| |spermicide, for a month before taking Roaccutane, during treatment and for a month afterwards. Before you start |
| |treatment your doctor will ask you to take a pregnancy test, which must be negative. |
| |You must use contraception even if you do not have periods or are not currently sexually active (unless your |
| |doctor decides this is not necessary). |
| |You must accept the need for monthly follow up visits and more pregnancy tests as decided by your doctor. You may |
| |have a test 5 weeks after stopping Roaccutane. You must not get pregnant during treatment and for a month |
| |afterwards. |
| |Your doctor may ask you (or a guardian) to sign a form that confirms that you have been told about the risks, and |
| |that you accept the necessary precautions. |
| |NetDoctor: |
| |You should avoid exposing your skin to intense sunlight or UV light while taking this medicine. You should use a |
| |sunscreen of at least SPF 15 when necessary. |
| |Isotretinoin is likely to make your skin and lips very dry, so it is recommended that you use a moisturiser and |
| |lip balm from the start of treatment. |
| |You should avoid waxing any part of your body while taking isotretinoin, and for at least six months after |
| |stopping treatment, as this could cause stripping of the top layer of skin. Chemical dermabrasion and cutaneous |
| |laser treatment should also be avoided during treatment with isotretinoin and for five to six months after |
| |stopping treatment, as this could cause scarring. |
| |Isotretinoin causes major birth defects (serious malformations of a developing foetus) if taken during pregnancy. |
| |For this reason your doctor will not prescribe the treatment to women who could get pregnant, unless the following|
| |criteria are met: At least one, but preferably two (for example the pill and condoms), effective methods of |
| |contraception must be used at all times to prevent pregnancy. Contraception must start at least four weeks before |
| |starting treatment, be used at all times during treatment and for at least four weeks after stopping treatment, |
| |even if you don't have a period. Your doctor cannot prescribe isotretinoin until you have been using effective |
| |contraception for at least a month and have had a negative pregnancy test. Your doctor is only allowed to |
| |prescribe 30 days supply of isotretinoin at a time. You will need to have a follow-up visit every month, at which |
| |you will have to have a negative pregnancy test before a new prescription can be issued. Five weeks after stopping|
| |treatment you should have a final pregnancy test to make sure you have not fallen pregnant. If you think there is |
| |a chance you could be pregnant, either during treatment, or in the first month after stopping treatment, you must |
| |consult your doctor immediately. |
|What advice would you give? |Well-known side effect of Roaccutane related to the high dose of vitamin A. |
|Or would you refer? | |
| |Avoid waxing any part of the body during therapy with isotretinoin, and for up to six months after stopping |
| |therapy, due to risk of inflammation of the skin (dermatitis) and scarring. |
|Further learning points |
|Isotretinoin, a Vitamin A analogue, is very toxic and may only be prescribed by / under supervision of a consultant dermatologist. It is |
|teratogenic. Women of childbearing age must be fully informed and practice effective contraception. |
Workshop 4.1: Adverse Drug Reactions
|Case Scenario 2 |
|Question |My son has a rash all over his body and is feeling unwell. He has recently started lamotrigine, could this be |
| |causing the rash? |
|What further background |PERSON |MEDICINES |
|information do you need to | | |
|clarify the question and | | |
|minimise the risks when | | |
|advising the caller? | | |
| |Who is asking? |Medicines (name,dose,freq)? |
| |Mother about 8 years old son. |Lamotrigine 5mg each day. |
| | |Sodium Valproate 200mg twice a day. |
| |New or worsening symptoms? |How long been on these, who prescribed them? |
| |Rash – raised red bumps., not bleeding, all over him. |Lamotrigine started about 3 weeks ago by specialist as |
| |Started yesterday evening. He is hot and feels unwell. |sodium valporate not controlling the fits. |
| | | |
| |Any allergies/medical conditions? | |
| |Epilepsy. | |
|Gather the further background information BEFORE searching for information. |
|What information sources |eBNF: |
|would you use? |Skin reactions Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (rarely |
| |with fatalities) have developed especially in children; most rashes occur in the first 8 weeks. Rash is sometimes |
| |associated with hypersensitivity syndrome (see Side-effects, above) and is more common in patients with history of|
| |allergy or rash from other antiepileptic drugs. Consider withdrawal if rash or signs of hypersensitivity syndrome |
| |develop. The CSM has advised that factors associated with increased risk of serious skin reactions include |
| |concomitant use of valproate, initial lamotrigine dosing higher than recommended and more rapid dose escalation |
| |than recommended. |
| |Counselling Warn patients to see their doctor immediately if rash or signs or symptoms of hypersensitivity |
| |syndrome develop |
| | |
| |eMC SPC/ Lamictal: |
| |Undesirable effects |
| |In double-blind, add-on clinical trials, skin rashes occurred in up to 10% of patients taking lamotrigine and in |
| |5% of patients taking placebo. The skin rashes led to the withdrawal of lamotrigine treatment in 2% of patients. |
| |The rash, usually maculopapular in appearance, generally appears within eight weeks of starting treatment and |
| |resolves on withdrawal of lamotrigine (see Special Warnings and Special Precautions for Use). |
| | |
| |Rarely, serious potentially life threatening skin rashes, including Stevens Johnson syndrome and toxic epidermal |
| |necrolysis (Lyell Syndrome) have been reported. Although the majority recover on drug withdrawal, some patients |
| |experience irreversible scarring and there have been rare cases of associated death. (See Special Warnings and |
| |Special Precautions for Use) |
| |The approximate incidence of serious skin rashes reported as SJS in adults and children over the age of 12 is 1 in|
| |1000. The risk in children under the age of 12 is higher than in adults. Available data from a number of studies |
| |suggest that the incidence in children under the age of 12 requiring hospitalisation due to rash ranges from 1 in |
| |300 to 1 in 100 (see Special Warnings and Special Precautions for Use). |
| | |
| |In children, the initial presentation of a rash can be mistaken for an infection; physicians should consider the |
| |possibility of a drug reaction in children that develop symptoms of rash and fever during the first eight weeks of|
| |therapy. |
| | |
| |Additionally the overall risk of rash appears to be strongly associated with:- |
| | |
| |High initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see |
| |Posology and Method of Administration). |
| | |
| |Concomitant use of valproate |
| | |
| | |
| |NetDoctor: |
| |Adverse skin reactions have been reported with lamotrigine. These reactions are usually mild and get better on |
| |their own, but can on rare occasions be more serious and potentially life-threatening. The risk is higher in |
| |children under 12 years of age and in people who are also taking the medicine valproate. When starting treatment |
| |with lamotrigine the dose is increased gradually to minimise the risk of developing a skin rash. For this reason |
| |it is very important to follow the instructions you are given with this medicine, and not to exceed the prescribed|
| |dose. If you or your child develop a rash, fever, facial swelling or swollen glands while taking this medicine you|
| |should consult your doctor immediately. If the doctor decides the reaction is related to this medicine you will |
| |need to stop taking it. |
|What advice would you give? |Rash is a common side effect of lamotrigine. It is usually red and raised and often begins within the first 8 |
|Or would you refer? |weeks of treatment. However, it can be a more serious side effect especially if there is also fever. |
| | |
| |Advise that the son sees the GP immediately or is taken to A&E. Please explain that you have phoned NHS Direct and|
| |this is what was advised. It is important that the rash be seen by a doctor and if due to lamotrigine then treated|
| |quickly. |
| | |
Workshop 4.1: Adverse Drug Reactions
|Case Scenario 3 |
|Question |My husband has recently started simvastatin and has developed muscle pain in his leg. Could it be due to this new|
| |drug? |
|What further background |PERSON |MEDICINES |
|information do you need to | | |
|clarify the question and | | |
|minimise the risks when | | |
|advising the caller? | | |
| | | |
| |Who is asking? |Medicines (name, dose, freq)? |
| |Wife about 62yr old husband. |Simvastatin 10mg once daily |
| | |Aspirin 75mg once daily |
| |New or worsening symptoms? | |
| |Muscle pain developed over last 24 hours in lower legs |How long has the patient been on these prescribed |
| |and generally feels unwell. |medications? |
| | |GP started simvastatin last week because cholesterol |
| |Any allergies/medical conditions? |level 5.7 |
| |High cholesterol |Aspirin taken for several years. |
|Gather the further background information BEFORE searching for information. |
|What information sources |eBNF: |
|would you use? |Side-effects |
| |Reversible myositis is a rare but significant side-effect of the statins (see also CSM advice (Muscle Effects), |
| |section 2.12 and below). The statins also cause headache, altered liver-function tests (rarely, hepatitis), |
| |paraesthesia, and gastro-intestinal effects including abdominal pain, flatulence, constipation, diarrhoea, nausea |
| |and vomiting. Rash and hypersensitivity reactions (including angioedema and anaphylaxis) have been reported |
| |rarely. |
| |Muscle effects Myalgia, myositis, and myopathy have been reported with the statins; if myopathy is suspected and |
| |creatine kinase is markedly elevated (more than 5 times upper limit of normal), or muscular symptoms are severe, |
| |treatment should be discontinued; in patients at high risk of muscle effects, a statin should not be started if |
| |creatine kinase is elevated. There is an increased incidence of myopathy if the statins are given at high doses or|
| |given with a fibrate (see also CSM advice), with lipid-lowering doses of nicotinic acid, or with |
| |immunosuppressants such as ciclosporin; close monitoring of liver function and, if symptomatic, of creatine kinase|
| |is required in patients receiving these drugs. Rhabdomyolysis with acute renal impairment secondary to |
| |myoglobinuria has also been reported. |
| |Counselling |
| |Advise patient to report promptly unexplained muscle pain, tenderness, or weakness. |
| |CSM advice (muscle effects) |
| |The CSM has advised that rhabdomyolysis associated with lipid-regulating drugs such as the fibrates and statins |
| |appears to be rare (approx. 1 case in every 100 000 treatment years) but may be increased in those with renal |
| |impairment and possibly in those with hypothyroidism (see also notes above). Concomitant treatment with drugs that|
| |increase plasma-statin concentration increase the risk of muscle toxicity; concomitant treatment with a fibrate |
| |and a statin may also be associated with an increased risk of serious muscle toxicity. |
| | |
| |eMC SPC- Zocor: |
| |Before the treatment All patients starting therapy with simvastatin, or whose dose of simvastatin is being |
| |increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, |
| |tenderness or weakness. |
| |Whilst on treatment If muscle pain, weakness or cramps occur whilst a patient is receiving treatment with a |
| |statin, their CK levels should be measured. If these levels are found, in the absence of strenuous exercise, to be|
| |significantly elevated (> 5 x ULN), treatment should be stopped. If muscular symptoms are severe and cause daily |
| |discomfort, even if CK levels are < 5 x ULN, treatment discontinuation may be considered. If myopathy is suspected|
| |for any other reason, treatment should be discontinued. |
| |eMC PIL - Zocor |
| |Tell your doctor quickly if you experience unexplained muscle pain, tenderness or weakness. This is because on |
| |rare occasions, there is a risk of muscle problems which may be serious, including muscle breakdown which can |
| |result in kidney damage. The doctor may perform a blood test to check the condition of your muscles before and |
| |after starting treatment. |
| |Things to note regarding muscle effects |
| |The risk of muscle breakdown is greater at higher doses of ‘Zocor’. |
| |The risk of muscle breakdown is greater in certain patients. Tell your doctor if any of the following applies to |
| |you: |
| |kidney problems |
| |thyroid problems |
| |you are more than 70 years old |
| |you have ever had muscle problems during treatment with cholesterol lowering medicines called "statins" (such as |
| |simvastatin, atorvastatin, pravastatin) or fibrates (such as gemfibrozil, bezafibrate). |
| |you or close family members have a hereditary muscle disorder. |
| |The risk of muscle problems can be greater if ‘Zocor’ is taken with certain medicines |
| |NetDoctor: |
| |This medicine may occasionally have side effects on the muscles. For this reason you should inform your doctor |
| |immediately if you experience any unexplained muscular symptoms such as pain, tenderness, cramps or weakness while|
| |taking this medicine. Your doctor may need to check for side effects on the muscles by taking a blood test to |
| |measure the level of a compound called creatine kinase (CK) in your blood. If this is the case, the test should |
| |not be done following strenuous exercise. |
|What advice would you give? |Statins may have very rare side effects on muscles. |
|Or would you refer? | |
| |Advise that the husband see the GP immediately. The GP may advise that you stop this medication and may wish to |
| |do some blood test. |
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related searches
- adverse drug effect definition
- fda adverse drug reaction definition
- who adverse drug reaction
- adverse drug reaction classification
- adverse drug reactions statistics
- adverse drug reaction policy
- adverse drug reaction scale
- adverse drug reaction reporting
- adverse drug reaction reporting form
- types of adverse drug events
- causes of adverse drug events
- adverse drug reaction probability scale